Noor Naif Al-Hakami. Pharm-D candidate (KSU)

Hypertension In Hemodialysis Patients Treated With Atenolol Or Lisinopril: A Randomized Controlled Trial (Rajiv Agarwal, Arjun D. Sinha, Maria K. Pappas, Terri N. Abraham and Getachew G. Tegegne ) Noor Naif Al-Hakami Pharm-D candidate (KSU) 2014

Introduction Worldwide, 2 million people with end-stage renal disease (ESRD) undergo maintenance hemodialysis The dialysis statistics prepared by the Saudi Center for Organ Transplantation (SCOT) at the end of year 2011 showed a total of 13,356 dialysis patients, 12,116 of them are treated by Hemodialysis Dialysis in the Kingdom of Saudi Arabia. Saudi J Kidney Dis Transpl [serial online] 2012 [cited 2014 May 17];23:881-9. Available from: http://www.sjkdt.org/text.asp?2012/23/4/881/98196

Introduction Among these patients, hypertension is common and is often poorly controlled Nonvolume mechanisms such as activation of the renin angiotensin system or the sympathoadrenal system are important to sustain hypertension in such patients Dialysis in the Kingdom of Saudi Arabia. Saudi J Kidney Dis Transpl [serial online] 2012 [cited 2014 May 17];23:881-9. Available from: http://www.sjkdt.org/text.asp?2012/23/4/881/98196

Previous studies: Meta-analyses of randomized trials suggest that the risk of cardiovascular events can be cut by a third by using antihypertensive drug therapy among hemodialysis patients especially when they are hypertensive However, it is not clear whether one class of antihypertensive agent is superior to others in improving cardiovascular outcomes

Objective: The purpose of this study was to determine among maintenance hemodialysis patients with echocardiographic left ventricular hypertrophy and hypertension whether in comparison with a β-blocker-based antihypertensive therapy, an angiotensin converting enzyme-inhibitor-based antihypertensive therapy causes a greater regression of left ventricular hypertrophy

Study question (PICOT): Does lisinopril causes a greater regression of left ventricular hypertrophy in maintenance hemodialysis patients with echocardiographic left ventricular hypertrophy and hypertension compared to atenolol in twelve months? P I C O T Hemodialysis patients with echocardiographic left ventricular hypertrophy and hypertension Lisinopril Atenolol Change from baseline (CFB) in left ventricular mass index (LVMI) Twelve months

Method: The Hypertension in Hemodialysis Patients Treated with Atenolol or Lisinopril (HDPAL) was a randomized, open-label, parallel group, active control, single-center trial The study was conducted between August 2005 and September 2013 at four dialysis units affiliated with Indiana University

Cont method Subjects were randomized in a 1:1 ratio to either atenolol or lisinopril using concealed opaque envelopes Random sequence was generated by a statistician using a computer program

Cont method A diagnosis of hypertension was made if the 44-h interdialytic ambulatory BP monitoring was 135 mmhg systolic or 85 mmhg diastolic Left ventricular hypertrophy was defined as echocardiographic left ventricular mass index (LVMI) of 104 g/m2 in women and 116 g/m2 in men

Cont method Target home BP was 140/90 mmhg or less study drugs were started at the lower dose and titrated upwards using specific protocol Subjects received atenolol 25 mg TIW or lisinopril 10 mg TIW, and the dose was doubled every 2 4 weeks up to a maximum dose of 100 mg TIW for atenolol and 40 mg TIW for lisinopril

Cont method The analysis was performed by intention to treat A mixed model was used with LVMI as the outcome variable All analyses were conducted using Stata version 11.2 (Stata Corp., College Station, TX, USA) The P values reported are two-sided and taken to be significant at <0.05 As several imbalances were noted in baseline characteristics that may have influenced the outcome of the study, a post-hoc subgroup analysis was performed

Results: Trial Flow

Results: Baseline characteristics of the study sample

Results: Nature and number of antihypertensive and other drugs

Results: BP profiles at baseline and over time Lisinopril Atenolol

Results: Time course of change in echocardiographic LVMI

Results: Serious adverse events

RCT Checklist

Critical Appraisal Skills Programme (CASP) Randomised Controlled Trials Checklist 31.05.13

Weak points *The method was strong and well described *Open label design *Single center study *There were imbalance in some baseline characteristics Strength points

Conclusion: Among predominantly black hemodialysis patients with hypertension and left ventricular hypertrophy, an initial strategy using atenolol, β-blocker therapy, is superior to ACE-inhibitor-based therapy Strict attention to dry weight and periodic home BP monitoring may further improve BP control and cause regression of left ventricular hypertrophy However, authors were unable to draw any conclusion regarding between group differences in the regression of left ventricular hypertrophy

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